Print

Mail

wiki links

FDA loses patience over GlaxoSmithKline QC problems

Angered by quality-control problems it said had dragged on for more than two years, the Food and Drug Administration used armed federal marshals to seize millions of tablets of two medicines from facilities in Tennessee and Puerto Rico operated by GlaxoSmithKline, the agency said Friday.

The drugs are the antidepressant Paxil CR, which had US$725 million in sales last year and is used by some 450,000 patients in the US each month; and Avandamet, a diabetes medicine, whose sales are undisclosed but are far smaller.

The FDA said that neither pill was medically necessary and that many alternatives existed for both. It added that it knew of no patients harmed by the poorly made pills and said patients could safely take any pills they had left.

Officials at both the agency and GlaxoSmithKline said they could not predict when or how the manufacturing problems would be resolved, though the company said it satisfied the agency's concerns about Paxil CR last November.

Despite the absence of evidence that the pills had harmed anyone, the agency said, a drug maker must be able to assure the public that its products are properly made.

"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said John M. Taylor, the agency's associate commissioner for regulatory affairs.

GlaxoSmithKline's shares slid US$1.59 Friday, to US$48.91, a decline of 3.15 percent.

The problems were detected when inspections beginning in February 2002 at the plant in Cidra, Puerto Rico, revealed that Paxil CR tablets tended to split, leaving patients with half a tablet with no medicine and another half with no buffering substance.

Avandamet is a combination of two diabetes drugs, Avandia and metformin. GlaxoSmithKline could not guarantee the potency of the Avandia portion, the agency said.

Officials said the problems persisted despite an FDA warning letter and more inspections. The company's inability to figure out what was going wrong was worrisome, they said.

Nancy Pekarek, a GlaxoSmithKline spokeswoman, said the company believed that it had resolved its dispute with the drug agency by recalling many of the pills made before November and inspecting those made afterward.

Paxil CR is a "controlled release" version of the antidepressant. Many analysts say GlaxoSmithKline created it to fight off generic competitors to Paxil in the US, where the CR version is almost exclusively sold. The company said that version was easier to tolerate than Paxil.

Still, Dr. James McGough, a professor of psychiatry at the University of California, Los Angeles, said, "Most patients who are currently receiving Paxil CR could easily switch to generic versions of Paxil without any loss of benefit."

Pekarek said that all "bi-layer" tablets like Paxil CR tended to split and that the company's new inspection process ensured that damaged tablets were not shipped to pharmacies.

FDA officials and a top drug manufacturing consultant dismissed that explanation, saying many companies were able to make bi-layer tablets that are not prone to splitting. They added that inspections were unlikely to catch all the damaged pills.

"You cannot just say you'll pick out the bad ones," said a top former GlaxoSmithKline manufacturing executive, speaking on condition of anonymity because he now consults for drug companies. "We're not making strawberries here."
This story has been viewed 4997 times.